Smoking Cessation for Depression and Anxiety Treatment

Smoking Clinical Trial

— SDAT  

Official title:

Integrated Smoking Cessation Treatment for Emotional Dysregulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002858
• Other study ID #: 1R34DA03474101
• Secondary ID: R34DA034741
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2013
• Last updated: July 6, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation, and anxiety and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ages 18-65 years old

• Capable of providing informed consent

• Willing to attend all study visits and comply with the protocol

• Daily smoker for at least one year

• Currently smoke an average of at least 6 cigarettes per day

• Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale

• Elevated anxiety or depression

Exclusion Criteria:

• Use of other tobacco products

• Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol

• Currently suicidal or high suicide risk

• Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt

• Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression

• Current or intended participation in a concurrent substance abuse treatment

• Current non-nicotine substance dependence

• Insufficient command of English to participate in assessment or treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression Disorders
• Depressive Disorder
• Disease
• Smoking

Intervention

Drug:
• Nicotine Patch

Behavioral:
• Depression and Anxiety Smoking Cessation Treatment
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
• Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program

Locations

Country	Name	City	State
United States	Anxiety and Health Research Laboratory and Substance Use Treatment Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Status using the Timeline Follow-Back Assessment	Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking).	Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.

External Links

•   Project Website